Danish Registry Analysis Finds Consistent Safety After Switching to Infliximab Biosimilar GP1111

February 03, 2026

New Danish registry data confirm the safety of switching to infliximab biosimilars, showing low rates of serious adverse events in patients with inflammatory arthritis.

Q&A With Chelsee Jensen, PharmD: FDA Policy Shifts, Biosimilar Development Hurdles, and Market Access in 2026

February 02, 2026

Early Evidence Supports KM118 as a Biosimilar to Reference Pertuzumab

January 28, 2026

Milestone Approvals, Evolving PBM Models May Redefine the 2026 Biosimilar Landscape

January 27, 2026

FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job

January 26, 2026

The Top 5 Biosimilar Articles for the Week of October 21

October 25th 2024

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of October 21, 2024.

FDA and Industry Experts Unpack Biosimilar Device Requirements

October 23rd 2024

By Skylar Jeremias

Article

At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.

Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims

October 23rd 2024

By Skylar Jeremias

Article

At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.

Unifying Standards: The Need for Streamlined Biosimilar Development

October 22nd 2024

By Skylar Jeremias

Article

At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.

GRx+Biosims: Panelists Discuss Regulatory Shifts in Biosimilar Interchangeability

October 22nd 2024

By Skylar Jeremias

Article

At the GRx+Biosims 2024 conference, panelists explored challenges and progress in biosimilar interchangeability regulations in the US, discussing the FDA's new draft guidance, the removal of switching study requirements, and the need for more education to reduce misinformation and improve biosimilar uptake.

BioRationality: Developer-Led Biosimilar Education Unnecessary, FDA’s Got It Covered

October 21st 2024

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, provides an overview of the current biosimilar education material offered by the FDA, emphasizing that manufacturer-developed materials aren't needed.

Addressing Hesitance in Biosimilar Adoption

October 20th 2024

By Skylar Jeremias

Video

Sophia Humphreys, PharmD, from Sutter Health explains that expanding biosimilars into new therapeutic areas faces hesitance due to maintenance therapies, emphasizing the importance of education.

Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis

October 19th 2024

By Deana Ferreri, PhD

Article

A phase 3, 28-week comparative clinical trial in patients with moderate to severe plaque psoriasis confirmed similarity of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the reference product (Stelara) in efficacy, safety, pharmacokinetics, and immunogenicity.

The Top 5 Biosimilar Articles for the Week of October 14

October 18th 2024

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of October 14, 2024.

Cost Savings and Efficacy of Biosimilars in Psoriasis Treatment for Veterans

October 17th 2024

By Skylar Jeremias

Article

Biosimilars are safe, effective, and well-tolerated for psoriasis treatment, providing significant cost savings for the Veterans Health Administration, which saved over $67 million in 2023, while highlighting ongoing provider concerns regarding their use.